510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+5K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+5K120869Anchor-L Lumbar CageStryker Spine2012638—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+5K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+5K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K120024Mectalif TransforaminalMedacta International S.A.201223—
+5K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+5K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+5K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+5K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+5K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+5K110915Cervical CageEisertech, LLC201123—
+5K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+5K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+5K103369Vault Alif SystemSpinal USA201110—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K093093Small Plateau Spacer SystemLife Spine2010393—
+5K101301Stalif MidlineCentinel Spine2010474—
+5K100889Endoskeleton TCTitan Spine, LLC2010455—
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+5K083475Lucent MagnumSpinal Elements, Inc.2009834—
+5K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+5K081711Lucent Magnum+Spinal Elements, Inc.20080—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K242303MOD-COrthomod, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—